NDAORALCAPSULE
Approved
May 1998
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
PROMETRIUM (progesterone) by Fresenius Kabi is clinical pharmacology prometrium capsules are an oral dosage form of micronized progesterone which is chemically identical to progesterone of ovarian origin. First approved in 1998.
Drug data last refreshed 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PROMETRIUM is an oral micronized progesterone capsule approved in 1998 for multiple gynecological indications including infertility, contraception, preterm birth prevention, menopause symptom management, and use in IVF protocols. It is chemically identical to naturally occurring ovarian progesterone and works by binding to progesterone receptors to support reproductive and endocrine function. The micronization technology enhances oral bioavailability, with peak serum concentrations achieved within 1.5–2.3 hours depending on dose.
LOE Approaching
Product is approaching end-of-life with generic entry imminent; commercial teams should anticipate workforce rightsizing and transition focus to life-cycle management and retention strategies.
Mechanism of Action
CLINICAL PHARMACOLOGY PROMETRIUM Capsules are an oral dosage form of micronized progesterone which is chemically identical to progesterone of ovarian origin. The oral bioavailability of progesterone is increased through micronization. Pharmacokinetics A. Absorption After oral administration of…
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.